Studieoverzicht - 2005-02 MATADOR
| Number | 2005-02 MATADOR | ||||
| Nickname | MATADOR | ||||
| Status | Follow up | Date: 11-10-2012 | |||
| Inclusion closed | |||||
| Other study number(s) | CKTO 2004-04 | ||||
| Participating parties/groups | |||||
| Full title | Microarray analysis in breast cancer to tailor adjuvant drugs or regimens, a randomized phase III study | ||||
| Phase and type | Randomized Phase II/III | ||||
| Age | ≥ 18; <65 | ||||
| Menopausal status | Both pre- and postmenopausal | ||||
| Indication | Adjuvant | ||||
| Subindication | Any HER2, any HR | ||||
| Target sample size | 660 | ||||
| Actual accrual | 661 | Date: 11-10-2012 | |||
| Estimated study completion date | 01-01-2012 | ||||
| CCMO approval | Not applicable | Date: | Nr: | ||
| EudraCT nr. | |||||
| Trial Register | ISRCTN61893718 | ||||
| METC approval | Yes | Date: 25-03-2004 | METC: Nederlands Kanker Instituut | Nr: M04MAT | |
| Amendments | Yes | Date: 27-04-2008 | |||
| KWF-CKS approval | Yes | Date: 01-01-2004 | Nr: CKTO 2004-04 | ||
| News item | |||||
| Website | http://www.boogstudycenter.nl | ||||
| Sponsor | NKI-AVL | ||||
| Principal Investigator(s) | S.C. Linn, H.M. Oosterkamp | |||
| Study manager | ||||
| Central datamanagement and randomization | NKI-AVL trialbureau Plesmanlaan 121 1066 CX Amsterdam Tel 020 5122668 Fax 020 5122679 E-mail trialbureau@nki.nl |
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| Monitoring | Not applicable | |||
| Local datamanagement | IKNL | |||
| Funding |
 Funding by KWF |
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| Extra | ||||
Design:
Randomization:
Arm A: Acdd 6 cycles versus
Arm B: TAC: 6 cycles
Objectives:
To define gene expression profiles that can predict a disease-free survival (DFS) advantage for either dose dense therapy, or docetaxel-containing chemotherapy.
Is docetaxel-doxorubicin-cyclophosphamide (TAC) better than doxorubicin-cyclophosphamide dose-dense (AC dd) concerning DFS, RFS, breast cancer specific survival and all cause survival?
Endpoints:
Primary endpoints:
- 5-year disease-free survival
- To define two subpopulations on the basis of the microarray data: one in which Acdd is best and one in which TAC is best
Secondary enpoints:
- DFS
- OS
- Proteomic profile
Main eligibility criteria:
- pT1-T3, pN0-3b, M0 mammaca (TNM 2002)
- Known Her2
- Women < 65 yrs
- Tumor tissue available (frozen/RNAlater)
Documents (public):
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